Effective date of final rule published in the Federal Register of June 23, 2015 (80 FR 35834) confirmed: June 22, 2016.

21 CFR Part 107

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of June 22, 2016, for the final rule that appeared in the Federal Register of June 23, 2015. The final rule amended the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula.

This final rule is effective June 22, 2016. See section VII of this document for information on the filing of objections. Submit either electronic or written objections and requests for a hearing by July 23, 2015.

21 CFR Part 107

Summary

The Food and Drug Administration (FDA or we) is amending the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula.

The Food and Drug Administration (FDA or we) is correcting a final rule that appeared in the Federal Register of June 10, 2014. The final rule revised our infant formula regulations by establishing requirements for current good manufacturing practices, including audits; establishing requirements for quality factors; and amending our quality control procedures, notification, and record and reporting requirements for infant formula. We issued the final rule to provide greater protection of infants who consume infant formula products. In this document, we correct some errors that appeared in the preamble to the final rule.

This final rule is effective July 10, 2014. The compliance date for manufacturers to meet the requirements of §§ 106.96(a), 106.96(e), 106.96(i)(5), 106.100(p)(2) and 106.100(q)(2) related to quality factors for eligible infant formulas is November 12, 2015. The compliance date for the remaining provisions of this final rule is September 8, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by July 10, 2014 (see section VII, the “Paperwork Reduction Act of 1995” section of this document).

21 CFR Parts 106 and 107

Summary

The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled “Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula” (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of February 10, 2014. The document revised our infant formula regulations to establish requirements for current good manufacturing practices, including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA took the action to improve the protection of infants who consume infant formula products. The document was published with an incorrect docket number. This document corrects that error.

Effective date: This interim final rule is effective July 10, 2014. Comment date: Interested persons may submit either electronic or written comments on this interim final rule by March 27, 2014. Paperwork Reduction Act date: Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 12, 2014, (see the “Paperwork Reduction Act of 1995” section of this document). The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of July 10, 2014.

21 CFR Parts 106 and 107

Summary

The Food and Drug Administration (FDA, the Agency, or we) is revising our infant formula regulations to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.

Submit either electronic or written comments on the proposed rule by July 1, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 16, 2013, (see the “Paperwork Reduction Act of 1995” section of this document).

21 CFR Part 107

Summary

The Food and Drug Administration (FDA) is proposing to amend the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula.